Quality issue keeps Apricus Biosciences from getting Swiss approval for Vitaros

Quality issues have kept San Diego, CA, drugmaker Apricus Biosciences from getting approval for Vitaros, its topically applied cream for erectile dysfunction. The product has been approved in Ireland, the Netherlands, Sweden and the U.K., but the company said Thursday that Swissmedic had turned down the drug. It is not that they have a problem with how the ED drug works. The regulators said the preclinical and clinical data were satisfactory and would likely support an approval. They have an issue with the targeted shelf life of the cold chain formulation and said it was not satisfactory for approval. Vitaros is the company's only approved product, and the drugmaker said it would appeal the decision. Release